Treatment of Insertional Achilles Tendinopathy with Ultrasound-Guided Intrabursal Retrocalcaneal Hyaluronic Acid Injection - a Prospective Study
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Treatment of insertional Achilles tendinopathy with ultrasound-guided intrabursal retrocalcaneal hyaluronic acid injection - a prospective study Omer Slevin ( [email protected] ) Meir Medical Center https://orcid.org/0000-0002-9294-525X David Segal Meir Medical Center Nissim Ohana Meir Medical Center Eugene Kots Meir Medical Center Viktor Feldman Meir Medical Center Meir Nyska Meir Medical Center Ezequiel Palmanovich Meir Medical Center Research article Keywords: Achilles tendon, Insertional Achilles tendinopathy, Enthesitis, Retrocalcaneal bursitis, Hyaluronic acid, Ultrasound, Sonography Posted Date: October 1st, 2020 DOI: https://doi.org/10.21203/rs.3.rs-32768/v1 License: This work is licensed under a Creative Commons Attribution 4.0 International License. Read Full License Page 1/12 Abstract Background Insertional Achilles tendinopathy (IAT) is a chronic degenerative enthesopathy involving brocartilage changes that resemble osteoarthritic changes in articular cartilage. Thus, our primary goal was to evaluate the effect of hyaluronic acid (HA) injections on IAT. Methods Fifteen IAT ankles (14 patients) were treated with three consecutive weekly ultrasound-guided retrocalcaneal intrabursal injections of hylan G-F 20 (Synvisc®). Patients answered the "Victorian Institute of Sport Assessment – Achilles" (VISA-A) questionnaire before every injection and on 1 month and 6 months follow-up visits. Univariate analysis was performed to identify differences in functional scores. Results The mean (VISA-A) score improved signicantly following HA injections from 34.8 ± 15.2 (range, 11-63) points before the rst injection to 53.6 ± 20.9 (range, 15-77) points after 1 month, and 50.7 ± 18.6 (20-75) points after 6 months. No adverse drug reactions were noted. Conclusions Three consecutive ultrasound-guided intrabursal retrocalcaneal HA injections were found in our cohort to be benecial in treating IAT. Trial registration NCT02368561. Registered 23 February 2015. https://clinicaltrials.gov/ct2/show/NCT02368561? term=insertional+achilles&draw=2&rank=2 1. Introduction Insertional Achilles tendinopathy (IAT) is a chronic degenerative enthesopathy, affecting both physically active and non-active individuals [1]. The diagnosis is mainly clinical and is based on posterior heel pain, localized to the insertion of the Achilles tendon, accompanied by local swelling and impaired function [2]. About 20% of the patients suffering from chronic Achilles overuse injury have clinical and histopathological signs of IAT [3]. The pathological process in IAT may also involve a retrocalcaneal bursitis [4]. Signicant histopathological degenerative changes in IAT were found not only in the tendon, but also in the calcaneal brocartilage layers surrounding the distal part of the retrocalcaneal bursa [5]. These degenerative changes were found to resemble changes to articular cartilage that occur in osteoarthritis [5,6]. Furthermore, the inammatory changes, such as retrocalcaneal bursitis, were Page 2/12 suggested to be secondary to the brocartilage degeneration [6]. Those ndings imply that IAT may not be merely an activity-related pathology, but rather a more complex process involving all parts of the enthesis [7-9]. The degenerative component in IAT has recently led researchers to suspect that arthritis-modifying agents, such as hyaluronic acid (HA), may be applicable in the treatment of IAT [5]. Several histological studies that investigated the effects of exogenous HA on enthesopathies have shown that HA can reduce inammatory mediators [10], inhibit cartilage degeneration [11], and promote neovascularization and growth of new sensory nerves [12]. Due to the osteoarthritic-like changes in the brocartilage, mainly in the calcaneal posterior wall, we hypothesized that retrocalcaneal intrabursal HA injections would have a benecial effect on IAT patients. The primary goal of this study was to evaluate the effect of this treatment modality for IAT. The secondary goal was to assess whether IAT can be categorized according to four distinct sonographic ndings and to correlate these ndings with the treatment outcomes. 2. Materials And Methods We conducted a prospective, uncontrolled, single-center study between the years 2015 and 2017. Fifteen IAT cases in 14 patients were treated by three consecutive weekly ultrasound-guided retrocalcaneal intrabursal injections of high-molecular hylan G-F 20 (Synvisc®; Genzyme Biosurgery, Genzyme Corporation, NJ, USA). Patients were followed in a specialized foot and ankle clinic for at least 6 months. An ethical approval was obtained from the local ethical committee (0082-14 MMC). All procedures performed were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. All participants signed an informed consent form. Inclusion criteria were a diagnosis of chronic IAT that was established by a foot and ankle orthopedic surgeon, and a rheumatology clinic assessment in which a systemic arthropathy was ruled out. The diagnosis was based on a history of pain at the calcaneal insertion of the Achilles tendon and a physical examination that revealed tenderness in the calcaneal insertion of the Achilles tendon. A mandatory radiographic work-up included an Magnetic resonance imaging (MRI) study of the relevant foot and ankle, by which the soft tissue was evaluated for both insertional and peritendinous edema. Exclusion criteria included previous surgical treatment such as retrocalcaneal osteotomy, retrocalcaneal injection of platelet-rich plasma (PRP) or steroids during the 6 months prior to the enrollment, previous two or more steroids injection, a history of Achilles tendon rupture or a previous calcaneal fracture. During the rst visit to the clinic, detailed demographic data, medical history and previous treatment modalities were documented. A physical examination was performed by one of the two abovementioned authors and the patients were asked to ll out the "VISA-A" questionnaire (see below). All the injections were performed by one experienced radiologist by the following technique: The patients were placed in a prone position with the knee slightly exed. The ultrasound probe was placed transverse to the Achilles tendon and the retrocalcaneal bursa. In the transverse sonographic view, the hypoechoic area (the Page 3/12 retrocalcaneal bursa) was situated between the Achilles tendon and the calcaneus (Figure 1). During the rst test, four different areas were examined to characterize the pathology process: A swelling and irregularity in the retrocalcaneal bursa, representing an inammatory process, an irregularity in the posterior calcaneal wall that represents arthritis, an irregularity in the Achilles tendon that represents tendinitis, and an enthesitis reected as an irregularity in the Achilles tendon insertion (Figure 2). Next, a 21-gauge needle was inserted from the lateral side into a point just anterior to the Achilles tendon and a volume of 1-2 ml of Synvisc® was injected into the retrocalcaneal bursa. The study product is a sterile, nonpyrogenic, elastoviscous uid containing hylans, a derivative of hyaluronan, the sodium salt of hyaluronic acid. Each 2 ml glass syringe of Synvisc® contains 16 mg of hylan G-F 20 (cross-linked hylan polymers; hylan A and B), 17 mg sodium chloride, 0.32 mg disodium hydrogen phosphate, and 0.08 mg sodium dihydrogen phosphate monohydrate. The hyaluronan is extracted from chicken combs and the puried material has an average molecular weight of 6,000 kDa. The dose was adapted according to intrabursal pressure and the procedure was terminated when the retrocalcaneal bursa appeared brimful on the sonographic view. The patients were asked to avoid vigorous exercise during the rst two days following the injection. Thereafter, the patients were instructed to try to return to full activity. For outcome evaluation, we used the Victorian Institute of Sport Assessment – Achilles (VISA-A) questionnaire [13]. This questionnaire was designed specically to assess the severity of Achilles tendinopathy. The questionnaire is a self-administered form that evaluates pain, function and activity level [13] and has been commonly used to monitor outcomes after different treatment modalities for Achilles tendinopathy. It was previously found to be valid, reliable and clinically relevant [13,14]. The scores range from 0 to 100 points, with higher scores indicative of better function. The minimum clinically important difference (MCID), which is dened as the smallest change on a scale that would be considered important to a patient, has been estimated to be between 6 and 12 points [15,16]. A detailed history of daily and sport activities, physical examination results and physical adverse events were assessed 1 month and 6 months following the primary injection. The patients were asked to answer the VISA-A questionnaire before every injection and on each follow-up visit. 2.1 Statistical analysis Descriptive statistics included means, medians, ranges, and standard deviations calculated for the demographic variables and the VISA-A scores. For evaluation of the difference from the baseline at 1 month and 6 months, we used a two-tailed Mann-Whitney U test for nonparametric variables. The level of signicance was set at p = 0.05. Analyses were performed using IBM SPSS-25 (Chicago, IL) statistical package software. 3. Results The mean age of patients, 12 males and 3 females, was 53.7 ± 11.5 (range,